Eustachian tube device

ABSTRACT

The present invention provides a device stenting the ET. The stent (device) provides enhanced ventilation and drainage to the middle ear. Also provided is a method for inserting the device into the Eustachian tube and through the isthmus of a human subject.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a National Phase Application of PCT InternationalApplication No. PCT/IL2008/000873, International Filing Date Jun. 26,2008, entitled “Eustachian Tube Device”, published on Dec. 31, 2008 asInternational Publication Number WO 2009/001358 claiming priority ofU.S. Provisional Patent Application No. 60/946,151, filed Jun. 26, 2007,both of which are incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The invention provides stent devices for adequate ventilation anddrainage for normal middle ear function.

BACKGROUND OF THE INVENTION

Adequate ventilation and drainage is essential for normal middle earfunction. The Eustachian tube is purported to function in middle earventilation, drainage, and protection. Chronic Eustachian tubedysfunction has been implicated in the pathogenesis of many otologicdisorders and is thought to be a principal cause of surgical failures.Patients with chronic middle ear disease have often been shown to have amechanical narrowing of the Eustachian tube, usually at the isthmus(junction of the bony and cartilaginous portions), other causes for ETdysfunction are functional disorders of the cartilaginous part.Narrowing of the isthmus alone was demonstrated to be an insufficientcause of otitis media. Increasing evidence was found that allergicdisease and reflux may be two of the most important contributors oftubal inflammation causing otitis media with effusion.

The tube is ordinarily closed in the resting position and dilates to theopen position typically with swallows, yawns, and with other voluntaryor involuntary efforts. Tubal opening typically lasts less than one-halfsecond. Closure of the tube is maintained by a valve-like function ofthe opposing mucosal surfaces, submucosal tissue, fat, muscle, andcartilage. The valve measures approximately 5 mm in length and lieswithin the cartilaginous portion of the ET located about 10 mm distalinto the tube from the nasopharyngeal orifice's posterior cushion ortorus tubarius. The patulous ET has been defined as an abnormal patencythat results in autophony

A common problem resulting from Eustachian tube dysfunction is OtitisMedia with Effusion (OME) or the presence of fluid in the middle earwith no signs or symptoms of acute ear infection. Persistent middle earfluid from OME results in decreased mobility of the tympanic membraneand serves as a barrier to sound conduction. OME may occur spontaneouslybecause of poor Eustachian tube function or as a response followingAcute Otitis Media. This usually occurs in infants and children aged 1-6y due to anatomical difference and physiological changes of theEustachian tube. At birth the tube is horizontal and 17 to 18 mm long.It grows to be at an incline of 45 degrees and reaches the length of 35mm in adulthood. Due to its' relatively horizontal position in childhoodand because it is shorter, infants are more likely to suffer fromEustachian tube dysfunction.

Most surgical procedures performed at this time involve bypassing theblocked Eustachian tube by implantation of a surgical prosthesis,usually in the tympanic membrane (ear drum), for ventilation of themiddle ear cavity via the external ear canal. Tympanostomy tubes arerecommended for initial surgery. Often, however, complications areencountered with such tubes. The main complications associated withtympanostomy tubes insertion are divided to early and late. Earlycomplications: persistent otorrehea 10-26%, blockage of the tube 0-9%,early extrusion, hearing loss. Late complications: persistentperforation after tube extrusion 3%. Scarring of the tympanic membrane,atrophic membrane 21-28%, granuloma 5-40%, Tympanosclerosis 40-65%,cholesteatoma 1%.

SUMMARY OF THE INVENTION

In one embodiment, the present invention provides a device for insertioninto a Eustachian tube in a subject providing pressure controlledventilation, and enhanced drainage, or a combination thereof to a middleear of a subject, comprising a shell, wherein the shell comprises aproximal end, a distal end, wherein the device occupies at least aportion of the proximal portion of said Eustachian tube of a subject.

In another embodiment, the present invention further provides a methodfor placing a device within an Eustachian tube of a subject, comprising:(a) loading said device onto an insertion apparatus, wherein said devicecomprises a shell, wherein said shell comprises a proximal end, a distalend wherein, said device occupies at least a portion of the proximal endof said Eustachian tube of a subject. (b) inserting said device usingsaid insertion apparatus through a nostril or mouth of said subject intosaid Eustachian tube; and (c) releasing said device from the apparatusin said Eustachian tube.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1. is schematic drawing of the Device-Stent placed in theEustachian tube in accordance with an embodiment of the invention. Theproximal end (3) occupies part of the proximal portion of the Eustachiantube and the distal end (4) occupies part of the distal portion of theEustachian tube.

FIG. 2. is a schematic three dimensional drawing of the Stent (8) with aside view in accordance with an embodiment of the invention. Theproximal cone (1) narrows from the proximal end (3) to the intermediateportion (5). The distal cone (2) widens towards the distal end (4). Diskshape, pressure actuated valve is located within the proximal cone (6).

FIG. 3. is a schematic three dimensional drawing of the Stent (9) with aside view in accordance with an embodiment of the invention. Theproximal cone (1) narrows from the proximal end (3) to the intermediateportion (5). The distal cone (2) widens towards the distal end (4). Ballshape, pressure actuated valve is located within the proximal cone (6).Also present on the proximal cone is an immobilizing means or anchoringmeans (7).

DETAILED DESCRIPTION OF THE INVENTION

In one embodiment, the invention provides a device for insertion into aEustachian tube in a subject providing pressure controlled ventilation,and enhanced drainage, or a combination thereof to a middle ear of asubject, comprising a shell, wherein the shell comprises a proximal end,a distal end, wherein the device occupies at least a portion of theproximal portion of the Eustachian tube of a subject. In anotherembodiment, the device of occupis only said Eustachian tube. In anotherembodiment, the device proximal and/or distal ends are placed within theEustachian tube. In another embodiment, the device proximal and/ordistal ends remain placed within the Eustachian tube. In anotherembodiment, the device proximal and/or distal ends anchor the device tothe Eustachian tube. In another embodiment, the device does not exceedthe boundaries of the Eustachian tube. In another embodiment, the shellis a coaxial shell. In another embodiment, the device is located withinthe proximal portion of the ET and does not extend beyond the proximalportion of the ET. In another embodiment, the device does not exceed theboundaries of the Eustachian tube. In another embodiment, the proximalportion of the ET is located between the proximal end of ET and theproximal end of the isthmus.

In another embodiment, the present invention provides a device forinsertion through the Eustachian tube providing enhanced ventilation,drainage, or a combination thereof to a middle ear of a subject,comprising a shell, wherein the shell comprises a proximal end, a distalend, and an intermediate portion, wherein the proximal end and thedistal end have a larger cross-section area than the intermediateportion cross-section area, wherein the intermediate portion fits withinan isthmus in a subject.

In another embodiment, the invention further provides a method forinserting a device into an Eustachian tube (ET) and through thenasopharynx into the ET of a subject, comprising: (a) loading the deviceonto an insertion apparatus, wherein the device comprises a shellcomprising a proximal end, a distal end, and an intermediate portion,wherein the proximal and the distal ends have a larger cross-sectionarea than the intermediate portion cross-section area, wherein theintermediate portion fits within the isthmus that is located in theEustachian tube in a subject; (b) inserting the device using aninsertion apparatus through a nostril or mouth of a subject into theisthmus; and (c) releasing the device from the apparatus and into theisthmus.

In another embodiment, the proximal end cross-section area is largerthan the distal end cross-section area. In another embodiment, thedevice further comprises an intermediate portion. In another embodiment,the proximal end and the distal end have a larger cross-section areathan the intermediate portion cross-section area, wherein saidintermediate portion fits within said Eustachian tube in said subject

In another embodiment, the invention provides a device for insertioninto a Eustachian tube in a subject providing pressure controlledventilation, and enhanced drainage, or a combination thereof to a middleear of a subject, comprising a shell, wherein the shell comprises aproximal end, a distal end, and an intermediate portion, wherein theproximal end and the distal end have a larger cross-section area thanthe intermediate portion cross-section area, wherein the intermediateportion fits within the Eustachian tube in a subject. In anotherembodiment, the device is inserted through the isthmus.

In another embodiment, the invention provides a device for insertionthrough the isthmus providing pressure control ventilation, and enhancedventilation, drainage, or a combination thereof to a middle ear of asubject, comprising a shell (FIGS. 2 and 3), wherein the shell comprisesa proximal end (3), a distal end (4), and an intermediate portion (5),wherein the proximal end and the distal end have a larger cross-sectionarea than the intermediate portion cross-section area, wherein theintermediate portion fits within an isthmus in a subject. In anotherembodiment, the intermediate portion is compressible and can extendalong the isthmus. In another embodiment, the device is packed in acompressed form and can extend along the isthmus. In another embodiment,the device is packed in a compressed form and can extend along the ET.In another embodiment, the shell is compressible and can extend alongthe isthmus.

In one embodiment, the invention provides a device for insertion throughthe isthmus providing enhanced ventilation, drainage, or a combinationthereof to a middle ear of a subject, comprising a coaxial shell,wherein the shell comprises a proximal end (3), a distal end (4), and anintermediate portion (5), wherein the proximal end and the distal endhave a larger cross-section area than the intermediate portioncross-section area, wherein the intermediate portion fits within anisthmus in a subject. In another embodiment, the intermediate portion iscompressible and can extend along the isthmus. In another embodiment,the shell is compressible and can extend along the isthmus.

In another embodiment, the device extends along the Eustachian tube. Inanother embodiment, the device extends along the proximal portion of theEustachian tube. In another embodiment, the device location is confinedto the Eustachian tube. In another embodiment, the device location isconfined to the proximal part of the Eustachian tube (proximal to theisthmus).

In another embodiment, the invention provides a device for stenting theEustachian tube providing pressure controlled ventilation or enhanceddrainage, or a combination thereof to a middle ear of a subjectcomprising a proximal end occupying the proximal portion of theEustachian tube and a distal end occupying the narrowed proximalportions of the Eustachian tube. In another embodiment, the inventionprovides a device for stenting the proximal portion of the Eustachiantube providing pressure controlled ventilation or enhanced drainage, ora combination thereof to a middle ear of a subject, wherein the devicecomprises a distal end occupying the narrowed proximal portions of theEustachian tube. In another embodiment, the invention provides a devicefor stenting the proximal portion of the Eustachian tube providingpressure controlled ventilation or enhanced drainage, or a combinationthereof to a middle ear of a subject, wherein the device comprises adistal end occupying a location in proximity to the isthmus. In anotherembodiment, the invention provides a device for stenting the proximalportion of the Eustachian tube providing pressure controlled ventilationor enhanced drainage, or a combination thereof to a middle ear of asubject comprising a cone, a funnel, or a triangular shape wherein thenarrow portion of the cone, funnel, or triangular shape is placed inproximity to the isthmus. In another embodiment, the invention providesa device for stenting the proximal portion of the Eustachian tubeproviding pressure controlled ventilation or enhanced drainage, or acombination thereof to a middle ear of a subject, wherein the devicecomprises a cone, a funnel, or a triangular shape wherein the narrowportion of the cone, funnel, or triangular shape is the distal end ofthe device. In another embodiment, the invention provides a device forstenting the proximal portion of the Eustachian tube providing pressurecontrolled ventilation or enhanced drainage, or a combination thereof toa middle ear of a subject comprising a cone, a funnel, or a triangularshape wherein the wide portion of the cone, funnel, or triangular shapeis the proximal end of the device. In another embodiment, the inventionprovides a device for stenting the proximal portion of the Eustachiantube providing pressure controlled ventilation or enhanced drainage, ora combination thereof to a middle ear of a subject comprising a cone, afunnel, or a triangular shape wherein the proximal end is an opening. Inanother embodiment, the invention provides a device for stenting theproximal portion of the Eustachian tube providing pressure controlledventilation or enhanced drainage, or a combination thereof to a middleear of a subject comprising a cone, a funnel, or a triangular shapewherein the distal end is an opening. In another embodiment, theinvention provides a device comprising a pressure actuated valve forstenting the proximal portion of the Eustachian tube providing pressurecontrolled ventilation or enhanced drainage, or a combination thereof toa middle ear of a subject comprising a cone, a funnel, or a triangularshape, wherein the narrow portion of the cone, funnel, or triangularshape is the distal end of the device.

In another embodiment, the invention provides a device for stenting theEustachian tube providing pressure controlled ventilation or enhanceddrainage, or a combination thereof to a middle ear of a subject. Inanother embodiment, the invention provides a stenting device to beplaced through the isthmus providing pressure controlled ventilation orenhanced drainage, or a combination thereof to a middle ear of asubject. In another embodiment, the intermediate portion of the deviceis placed within the isthmus providing pressure controlled, drainage, ora combination thereof to a middle ear of a subject. In anotherembodiment, the intermediate portion of the device is placed within theisthmus and extends proximally and distally over the isthmus In anotherembodiment, the extensions of the intermediate portion over the end ofthe isthmus result in a proximal end and a distal end of the device. Inanother embodiment, the extensions of the intermediate portion beyondthe isthmus, and within the Eustachian tube.

In another embodiment, the intermediate portion of the device isdesigned to be placed within the narrow isthmus while the proximal endand a distal end are situated proximally and distally to the isthmuswithin the wider Eustachian tube. In another embodiment, theintermediate portion of the device is narrow while the proximal end andthe distal end of the device are wider. In another embodiment, theproximal end and the distal end of the device protrude outside of theisthmus into the Eustachian tube. In another embodiment, the proximalend cross-section area is larger than the distal end cross-section area.In another embodiment, the distal end cross-section area is larger thanany cross-section are within the intermediate portion. In anotherembodiment, the proximal end and the distal end are openings. In anotherembodiment, an interconnecting space is located between the proximal endand the distal end.

In another embodiment, the openings have narrower diameter than both theproximal end diameter and the distal end diameter. In anotherembodiment, the proximal opening and the distal opening have the samediameter. In another embodiment, the proximal opening and the distalopening have a different diameter. In another embodiment, the proximalend and the distal end are interconnected by a tube.

In another embodiment, the proximal end cross-section area is at least1.2 times larger than the distal end cross-section area. In anotherembodiment, the proximal end cross-section area is at least 1.4 timeslarger than the distal end cross-section area. In another embodiment,the proximal end cross-section area is at least 1.5 times larger thanthe distal end cross-section area. In another embodiment, the proximalend cross-section area is at least 1.8 times larger than the distal endcross-section area. In another embodiment, the proximal endcross-section area is at least 2 times larger than the distal endcross-section area. In another embodiment, the proximal endcross-section area is at least 2.5 times larger than the distal endcross-section area. In another embodiment, the proximal endcross-section area is at least 3 times larger than the distal endcross-section area. In another embodiment, the proximal endcross-section area is at least 4 times larger than the distal endcross-section area. In another embodiment, the proximal endcross-section area is at least 5 times larger than the distal endcross-section area. In another embodiment, the proximal endcross-section area is at least 6 times larger than the distal endcross-section area. In another embodiment, the proximal endcross-section area is at least 8 times larger than the distal endcross-section area. In another embodiment, the proximal endcross-section area is at least 10 times larger than the distal endcross-section area.

In another embodiment, the device diameter is between 0.3-6 mm. Inanother embodiment, the device diameter is between 0.5-4 mm. In anotherembodiment, the device diameter is between 1-6 mm. In anotherembodiment, the device diameter is between 1-5 mm. In anotherembodiment, the device diameter is between 2-5 mm. In anotherembodiment, the device diameter is between 2-4 mm. In anotherembodiment, the device diameter is between 3-6 mm. In anotherembodiment, the device diameter is between 0.3-3 mm.

In another embodiment, the device width regardless of its shape (i.e.tube, triangular, etc.) is between 0.3-6 mm. In another embodiment, thedevice width regardless of its shape (i.e. tube, triangular, etc.) isbetween 1-6 mm. In another embodiment, the device width regardless ofits shape (i.e. tube, triangular, etc.) is between 0.5-5 mm: In anotherembodiment, the device width regardless of its shape (i.e. tube,triangular, etc.) is between 1-5 mm. In another embodiment, the devicewidth regardless of its shape (i.e. tube, triangular, etc.) is between0.3-4 mm. In another embodiment, the device width regardless of itsshape (i.e. tube, triangular, etc.) is between 3-6 mm. In anotherembodiment, the device width regardless of its shape (i.e. tube,triangular, etc.) is between 0.3-3 mm. In another embodiment, the devicewidth regardless of its shape (i.e. tube, triangular, etc.) is between0.5-4 mm.

In another embodiment, the distal end cross-section area is at least 1.2times larger than the largest cross-section area situated within theintermediate portion. In another embodiment, the distal endcross-section area is at least 1.5 times larger than the largestcross-section area situated within the intermediate portion. In anotherembodiment, the distal end cross-section area is at least 1.8 timeslarger than the largest cross-section area situated within theintermediate portion. In another embodiment, the distal endcross-section area is at least 2 times larger than the largestcross-section area situated within the intermediate portion. In anotherembodiment, the distal end cross-section area is at least 3 times largerthan the largest cross-section area situated within the intermediateportion. In another embodiment, the distal end cross-section area is atleast 4 times larger than the largest cross-section area situated withinthe intermediate portion. In another embodiment, the distal endcross-section area is at least 5 times larger than the largestcross-section area situated within the intermediate portion.

In another embodiment, the proximal end cross-section area is at least1.2 times larger than the largest cross-section area situated within theintermediate portion. In another embodiment, the proximal endcross-section area is at least 1.5 times larger than the largestcross-section area situated within the intermediate portion. In anotherembodiment, the proximal end cross-section area is at least 1.8 timeslarger than the largest cross-section area situated within theintermediate portion. In another embodiment, the proximal endcross-section area is at least 2 times larger than the largestcross-section area situated within the intermediate portion. In anotherembodiment, the proximal end cross-section area is at least 3 timeslarger than the largest cross-section area situated within theintermediate portion. In another embodiment, the proximal endcross-section area is at least 4 times larger than the largestcross-section area situated within the intermediate portion. In anotherembodiment, the proximal end cross-section area is at least 5 timeslarger than the largest cross-section area situated within theintermediate portion.

In another embodiment, the shell is a coaxial shell. In anotherembodiment, the shell is continuous. In another embodiment, the shellmade of a single piece of material. In another embodiment, the shell isnot continuous. In another embodiment, the shell. In another embodiment,the shell comprises an array of spaces. In another embodiment, the term“array” refers to an arrangement of a discontinuos shell or spaceswithin the shell. In another embodiment, the array of this inventioncomprises spaces positioned on the array so as to form any desiredgeometrical shape including a circle, square, rectangle, triangle,polygons or other, as will be understood by one skilled in the art andwill be so formed to suit a desired application. In another embodiment,a square arrangement of spaces in rows and columns, as in a matrix isbeing used. In another embodiment, positioning on the array with aparticular pattern is desired, for example, spaces of varying geometriesare positioned within a pattern. In another embodiment, a spacepositioning in the array is a function of the material applied to theshell. In another embodiment, the device may comprise more than onearray. In another embodiment, the arrays may be arranged perpendicularwith respect to each other, or in another embodiment, in parallel. Inanother embodiment, arrays might radiate outward from a single point, asspikes on a wheel.

In another embodiment, the shell is a spiral. In another embodiment, theshell is a coil. In another embodiment, the shell is a network of coils.In another embodiment, the shell is a spring.

In another embodiment, the shell is compressible. In another embodiment,the shell is extendable. In another embodiment, the shell isstretchable. In another embodiment, the shell is elastic. In anotherembodiment, the shell comprises rigid or semi rigid portions and elasticportions. In another embodiment, the intermediate portion iscompressible and can extend along the isthmus. In another embodiment,the intermediate portion is compressible and can extend along theEustachian tube.

In another embodiment, the device is an implantable device that ispositioned within an anatomical cavity of the isthmus. In anotherembodiment, the device is an implantable device that is positionedwithin the anatomical cavity of the Eustachian tube to deliver adiagnostic to the Eustachian tube, tissues located adjacent to, or nearthe implanted device. In another embodiment, the device is animplantable device that is positioned within the anatomical cavity ofthe isthmus to deliver a diagnostic to the isthmus, tissues locatedadjacent to, or near the implanted device. In another embodiment, thedevice is an implantable device that is positioned within the Eustachiantube to support the Eustachian tube as an open passage. In anotherembodiment, the device is an implantable device that is positionedwithin the proximal portions of the Eustachian tube (proximal to theisthmus) to support the Eustachian tube as an open passage. In anotherembodiment, the device is an implantable device that is positionedwithin an anatomical cavity of the isthmus to support the isthmus as anopen passage. In another embodiment, the device is an implantable devicethat is positioned within an anatomical cavity of the isthmus to supportthe Eustachian tube as an open passage.

In another embodiment, the shell is desirably compressive by anyconstruction (e.g., a single tube element with ends that allow somecompression. In another embodiment, the intermediate portion is a hollowtubular body. In another embodiment, the dimensions of the device can bevaried in keeping with the variable dimensions of the human adult andpediatric Eustachian tubes. In another embodiment, the overall length ofthe device is about 15 to 40 mm. In another embodiment, the overalllength of the device is about 20 to 30 mm. In another embodiment, theoverall length of the device is about 22 to 26 mm. In anotherembodiment, the outside diameter of the proximal end is about 2 to 12mm. In another embodiment, the outside diameter of the proximal end isabout 4 to 10 mm. In another embodiment, the outside diameter of theproximal end is about 6 to 12 mm. In another embodiment, the outsidediameter of the proximal end is about 6 to 10 mm. In another embodiment,the outside diameter of the distal end is about 2 to 8 mm. In anotherembodiment, the outside diameter of the distal end is about 3 to 7 mm.In another embodiment, the outside diameter of the distal end is about 3to 6 mm. In another embodiment, the outside diameter of the distal endis about 3 to 5 mm. In another embodiment, the outside diameter of thedistal end is about 4 to 5 mm.

In another embodiment, the device is 20 mm to 50 mm long. In anotherembodiment, the device is 30 mm to 50 mm long. In another embodiment,the device is 30 mm to 40 mm long. In another embodiment, the device is31 mm to 38 mm long. In another embodiment, the device is 4 mm to 10 mmlong. In another embodiment, the device is 4 mm to 50 mm long. Inanother embodiment, the device is 10 mm to 20 mm long. In anotherembodiment, the device is 15 mm to 30 mm long. In another embodiment,the device has an inverted S-shape.

In another embodiment, the device is comprised of a biocompatiblematerial. In another embodiment, the device is comprised of acombination of biocompatible materials. In another embodiment, thedevice is comprised of a biocompatible material that provides thenecessary physical properties for the device of the invention. Inanother embodiment, the device is comprised of a polymeric material(both natural and synthetic), a polymeric fiber, a ceramic material, acomposite material, a metal, a metal oxide, and combinations thereof. Inanother embodiment, the device is comprised of amylose and amylopectinderivatives, polyamides, polyvinyl alcohol, polyvinyl acetals,polyvinylpyrrolidone, polyacrylates, epoxy resins, and polyurethanes(mixtures thereof, blends with other ingredients, or copolymers thereof)and combinations thereof.

In another embodiment, the device is coated. In another embodiment, thedevice is coated with a polymer or coating composition. In anotherembodiment, the device is coated with hyaluronic acid. In anotherembodiment, the device is coated with Perylenem™. In another embodiment,the device is coated with heparin. In another embodiment, the device iscoated with a lubricant. In another embodiment, the device is coatedwith a thrombo-prevention compound. In another embodiment, the device iscoated with an anti-bacterial compound. In another embodiment, thedevice is coated with an anti-inflammatory compound. In anotherembodiment, the device is cross-linked or bound to a drug by gammairradiation, chemical binding (as with binder or crosslinking moleculessuch as N-hydroxysuccinimide), or any other method. In anotherembodiment, the device is capable of the controlled release of a drugsuch as a surfactant, lubricant, antibiotic, anti-acid, antifungalagent, anti-inflammatant, or the like, which has been shown to decreasethe end pressure of the Eustachian tube.

In another embodiment, the device is formed in part or in whole from anumber of materials. In another embodiment, the materials are typicallyselected so as to ensure optimal device performance given the particularconstruction and/or geometry of the device. In another embodiment, thematerials are tailored to the environment conditions to which the devicemay be exposed. In another embodiment, the environmental conditions ofthe Eustachian tube may vary according to a number of factors, e.g., theparticular temperature of the animal whose Eustachian is to receive thedevice, whether the Eustachian tube is healthy or diseased, whether pusor other bodily fluids are present, edema of the mucosa, absent of thefat pad, etc.

In another embodiment, the device is substantially uniform incomposition. In another embodiment, the device comprises of a pluralityof regions that form an integrated whole. In another embodiment, thedevice is comprised of an interior region and a peripheral region,wherein the regions exhibit different compositions. In anotherembodiment, the peripheral region is formed from a biocompatiblematerial. In another embodiment, the microstructure of the materialsused with the invention is controlled in order to produce a device ofcontrolled mechanical properties (e.g., tensile strength, elasticity).In another embodiment, the material is typically synthetic or man-made.In another embodiment, naturally occurring composition are used. Inanother embodiment, biocompatibility requires a material purity of apharmaceutically acceptable grade.

In another embodiment, the material is a hydrophilic polymer. In anotherembodiment, the material hydrophilic polymers include polyethyleneglycol, polyoxyethylene, polymethylene glycol, polytrimethylene glycols,polycinylpyrrolidones, and derivatives thereof. In another embodiment,the polymers are linear or multiply branched. In another embodiment, thematerial is polyethylene glycol (PEG) containing compound. In anotherembodiment, the material is a polyvinyl alcohol, polyacrylic acid,polyglycolic acid, polydioxanone. In another embodiment, the material isa biodegradable material such as polyesters of an α-hydroxy acids,lactic acid, glycolic acid, lactic esters, caprolactone,polyether-polyester combinations especially of polyethylene glycol (PEG)and aliphatic polyesters like poly (lactic acid), poly (glycolic acid)and poly (caprolactone), either as a blend or as a copolymer, in orderto increase the hydrophilicity and degradation rate. In anotherembodiment, the material is a biodegradable polyanhydrides orpolyorthoesters having labile backbone linkages.

In another embodiment, the material is a polysaccharide. In anotherembodiment, the material is hyaluronic acid. In another embodiment, thematerial is cyclodextrin. In another embodiment, the material ishydroxymethylcellulose. In another embodiment, the material is celluloseether. In another embodiment, the material is a glycan. In anotherembodiment, the material is a collagen and other collagenic(collagen-like) materials

In another embodiment, the device is used in conjunction withpharmaceutical technologies known in the art. In another embodiment, theshell includes a pharmacologically active constituent. In anotherembodiment, a pharmacologically active constituent is bound to thedevice member or may be eludable. In another embodiment, suchpharmacologically active constituents may promote post-operative healingand may include, for example, antibiotics, antifungal agent,anti-inflammatory, or the like. In another embodiment, the biocompatiblematerial may be free from any pharmacologically active constituents.

In another embodiment, the device comprises a pharmaceutical substancethat treats or prevents a microbial infection, the substance deliveredmay comprise pharmaceutically acceptable salt or dosage form of anantimicrobial agent (e.g., antibiotic, antiviral, antiparacytic,antifungal, etc.), a corticosteroid or other anti-inflammatory (e.g., anNSAID), a decongestant (e.g., vasoconstrictor), a mucous thinning agent(e.g., an expectorant or mucolytic), an agent that prevents of modifiesan allergic response (e.g., an antihistamine, cytokine inhibitor,leucotriene inhibitor, IgE inhibitor, immunomodulator), etc.

In another embodiment, the device comprises acyclovir, amantadine,aminoglycosides (e.g., amikacin, gentamicin and tobramycin),amoxicillin, amoxicillin/clavulanate, amphotericin B, ampicillin,ampicillin/sulbactam, atovaquone, azithromycin, cefazolin, cefepime,cefotaxime, cefotetan, cefpodoxime, ceftazidime, ceftizoxime,ceftriaxone, cefuroxime, cefuroxime axetil, cephalexin, chloramphenicol,clotrimazole, ciprofloxacin, clarithromycin, clindamycin, dapsone,dicloxacillin, doxycycline, erythromycin, fluconazole, foscarnet,ganciclovir, atifloxacin, imipenem/cilastatin, isoniazid, itraconazole,ketoconazole, metronidazole, nafcillin, nafcillin, nystatin, penicillin,penicillin G, pentamidine, piperacillin/tazobactam, rifampin,quinupristin-dalfopristin, ticarcillin/clavulanate,trimethoprim/sulfamethoxazole, valacyclovir, vancomycin, mafenide,silver sulfadiazine, mupirocin, nystatin, triamcinolone/nystatin,clotrimazole/betamethasone, clotrimazole, ketoconazole, butoconazole,miconazole, tioconazole, detergent-like chemicals that disrupt ordisable microbes (e.g., nonoxynol-9, octoxynol-9, benzalkonium chloride,menfegol, and N-docasanol); chemicals that block microbial attachment totarget cells and/or inhibits entry of infectious pathogens (e.g.,sulphated and sulponated polymers such as PC-515 (carrageenan),Pro-2000, and Dextrin 2 Sulphate); antiretroviral agents (e.g., PMPAgel) that prevent retroviruses from replicating in the cells;genetically engineered or naturally occurring antibodies that combatpathogens such as anti-viral antibodies genetically engineered fromplants known as “plantibodies;” agents which change the condition of thetissue to make it hostile to the pathogen (such as substances whichalter mucosal pH (e.g., Buffer Gel and Acidform); non-pathogenic or“friendly” microbes that cause the production of hydrogen peroxide orother substances that kill or inhibit the growth of pathogenic microbes(e.g., lactobacillus); antimicrobial proteins or peptides, or anycombination thereof.

In another embodiment, the device comprises a pharmaceutical compositionthat treats or prevents inflammation; the substances delivered in thisinvention may include various steroids or other anti-inflammatory agents(e.g., nonsteroidal anti-inflammatory agents or NSAIDS), analgesicagents or antipyretic agents. For example, corticosteroids that havepreviously administered by intranasal administration may be used, suchas beclomethasone (Vancenase® or Beconase®), flunisolide (Nasalide®),fluticasone proprionate (Flonase®), triamcinolone acetonide (Nasacort®),budesonide (Rhinocort Aqua®), loterednol etabonate (Locort) andmometasone (Nasonex®). Other salt forms of the aforementionedcorticosteroids may also be used. Also, other non-limiting examples ofsteroids that may be useable in the present invention include but arenot limited to aclometasone, desonide, hydrocortisone, betamethasone,clocortolone, desoximetasone, fluocinolone, flurandrenolide, mometasone,prednicarbate; amcinonide, desoximetasone, diflorasone, fluocinolone,fluocinonide, halcinonide, clobetasol, augmented betamethasone,diflorasone, halobetasol, prednisone, dexamethasone andmethylprednisolone. Other anti-inflammatory, analgesic or antipyreticagents that may be used include the nonselective COX inhibitors (e.g.,salicylic acid derivatives, aspirin, sodium salicylate, cholinemagnesium trisalicylate, salsalate, diflunisal, sulfasalazine andolsalazine; para-aminophenol derivatives such as acetaminophen; indoleand indene acetic acids such as indomethacin and sulindac; heteroarylacetic acids such as tolmetin, dicofenac and ketorolac; arylpropionicacids such as ibuprofen, naproxen, flurbiprofen, ketoprofen, fenoprofenand oxaprozin; anthranilic acids (fenamates) such as mefenamic acid andmeloxicam; enolic acids such as the oxicams (piroxicam, meloxicam) andalkanones such as nabumetone) and Selective COX-2 Inhibitors (e.g.,diaryl-substituted furanones such as rofecoxib; diaryl-substitutedpyrazoles such as celecoxib; indole acetic acids such as etodolac andsulfonanilides such as nimesulide), or any combination thereof.

In another embodiment, the device comprises a pharmaceutical compositionthat treats or prevents an allergic or immune response and/or cellularproliferation, the substances delivered in this invention may include a)various cytokine inhibitors such as humanized anti-cytokine antibodies,anti-cytokine receptor antibodies, recombinant (new cell resulting fromgenetic recombination) antagonists, or soluble receptors; b) variousleucotriene modifiers such as zafirlukast, montelukast and zileuton; c)immunoglobulin E (IgE) inhibitors such as Omalizumab (an anti-IgEmonoclonal antibody formerly called rhu Mab-E25) and secretory leukocyteprotease inhibitor) and d) SYK Kinase inhibitoers, or any combinationthereof.

In another embodiment, the device comprises a pharmaceutical compositionthat shrinks mucosal tissue, cause decongestion or effect hemostasis,the substances delivered in this invention may include variousvasoconstrictors for decongestant and or hemostatic purposes includingbut not limited to pseudoephedrine, xylometazoline, oxymetazoline,phenylephrine, epinephrine, etc.

In another embodiment, the device comprises a pharmaceutical compositionthat facilitates the flow of mucous, the substances delivered in thisinvention may include various mucolytics or other agents that modify theviscosity or consistency of mucous or mucoid secretions, including butnot limited to acetylcysteine (Mucomyst™, Mucosil™) and guaifenesin.

In another embodiment, the device comprises a pharmaceutical compositionthat comprises any combination of an active pharmaceutical ingredient asdescribed herein.

In another embodiment, the device is produced by pouring a sterilesolution of a precursor member material onto a sterile mold. In anotherembodiment, the mold is composed of a biocompatible material. In anotherembodiment, the mold is composed of stainless steel. In anotherembodiment, the mold is composed of a biodegradable material or acombination of biodegradable materials. In another embodiment, the moldis composed of elastomeric or thermoplastic tubing. In anotherembodiment, the mold is composed of a glass. In another embodiment, thereleasing agent is interposed between the mold and the solution. Inanother embodiment, the shell is cast.

In another embodiment, the stent devices as described herein provideadequate ventilation and drainage for normal middle ear function. Inanother embodiment, the stent devices as described herein restoreventilation and drainage for normal middle ear function. In anotherembodiment, the stent devices as described herein enhance ventilationand drainage for normal middle ear function. In another embodiment, thestent devices as described herein regulate ventilation and drainage fornormal middle ear function. In another embodiment, the stent devices asdescribed herein regulate air flow for normal middle ear function. Inanother embodiment, the stent devices as described herein regulateliquid flow for normal middle ear function. In another embodiment, thestent devices as described herein regulate pressure within theEustachian tube for normal middle ear function. In another embodiment, astent device confined to the Eustachian tube regulates pressure withinthe Eustachian tube for normal middle ear function. In anotherembodiment, the stent devices as described herein treat middle earinflammation. In another embodiment, the stent devices as describedherein treat reoccurring otitis media. In another embodiment, the stentdevices as described herein treat chronic otitis media. In anotherembodiment, the stent devices as described herein treat dysfunctionalET. In another embodiment, the stent devices as described herein treatpatulous ET. In another embodiment, the stent devices as describedherein are drug eluting stent.

In another embodiment, the device is inserted for a long period of time.In another embodiment, the device remains in the isthmus for a longperiod of time. In another embodiment, the device remains in the isthmusfor at least one year. In another embodiment, the device remains in theisthmus for at least two years. In another embodiment, the deviceremains in the isthmus for at least three years. In another embodiment,the device remains in the isthmus for at least four years. In anotherembodiment, the device remains in the isthmus for at least five years.In another embodiment, the device remains in the isthmus for at leastseven years. In another embodiment, the device remains in the isthmusfor at least ten years. In another embodiment, the device remains in theisthmus for at least sixteen years. In another embodiment, the deviceremains in the isthmus for at least twenty years.

In another embodiment, the device remains in the isthmus for at leastone year. In another embodiment, the device remains in the isthmus forat least a month. In another embodiment, the device remains in theisthmus for at least three months. In another embodiment, the deviceremains in the isthmus for at least four months. In another embodiment,the device remains in the isthmus for at least five months. In anotherembodiment, the device remains in the isthmus for at least seven months.

In another embodiment, the device is inserted for a short period oftime. In another embodiment, the device remains in the isthmus for nomore than a year. In another embodiment, the device remains in theisthmus for no more than eight months. In another embodiment, the deviceremains in the isthmus for 2-8 weeks. In another embodiment, the deviceremains in the isthmus for 4-12 weeks. In another embodiment, the deviceremains in the isthmus for 10-35 weeks.

In another embodiment, the device is inserted into the Eustachian tubefor a short period of time. In another embodiment, the device remains inthe Eustachian tube for 2-8 weeks. In another embodiment, the deviceremains in the Eustachian tube for 6-12 weeks. In another embodiment,the device remains in the Eustachian tube for 1-3 months. In anotherembodiment, the device remains in the Eustachian tube for 2-6 months. Inanother embodiment, the device remains in the Eustachian tube for 4-12months. In another embodiment, the device remains in the Eustachian tubefor at least a year. In another embodiment, the device remains in theEustachian tube for at least two years. In another embodiment, thedevice remains in the Eustachian tube for at least three years. Inanother embodiment, the device remains in the Eustachian tube for atleast four years.

In another embodiment, the device is degraded at a programmed rate. Inanother embodiment, the device is designed to degrade at a rate whereinstructure may be completely removed by aqueous solution flushing intwenty-four months, eighteen months, twelve months or the like. Inanother embodiment, the device maintains sufficient structural integrityto maintain patency of the Eustachian tube for a designed period oftime. In another embodiment, the period of treatment may be for a periodbetween two weeks, two months, six months, twelve months or more.

In another embodiment, a measure of the ability to maintain structuralintegrity would be that the stent can sustain a radially applied forcewithout breaking (after the defined period of time) that is at leastone-half of the structural force that can be sustained prior toimplantation or immersion in a test environment. In another embodiment,the device comprises a lubricious, biologically neutral surface capableof eluting a surface-active agent, thereby mimicking the function of thenormal Eustachian tube.

In another embodiment, it is well-known in the art that chemicalmaterials, including lubricants, medicaments, and the like, may bedissolved or dispersed in a polymer and this will bloom or exude ormigrate from the polymer for local delivery of the material.

In another embodiment, the device comprises an insertable member whichcomprises a shell. In another embodiment, the device comprises aninsertable member which comprises an immobilizing means. In anotherembodiment, the insertable member provides sufficient air flow, gasflow, fluid flow, or any combination thereof. In another embodiment, theshell provides pressure control, sufficient air flow, gas flow, fluidflow, or any combination thereof.

In another embodiment, the device provides sufficient air communicationbetween the ends of the Eustachian tube, gas communication between theends of the Eustachian tube, fluid communication between the ends of theEustachian tube, or any combination thereof. In another embodiment, thedevice provides sufficient air communication between the middle ear andthe nasopharynx (unidirectional). In another embodiment, the deviceprovides unidirectional fluid communication and bidirectional aircommunication between the middle ear and the nasopharynx. In anotherembodiment, the device provides sufficient air communication between theproximal end and the distal end of the Eustachian tube, gascommunication between the proximal end and the distal end of theEustachian tube, fluid communication between the proximal end and thedistal end of the Eustachian tube, or any combination thereof. Inanother embodiment, the shell provides sufficient air communicationbetween the ends of the Eustachian tube, gas communication between theends of the Eustachian tube, fluid communication between the ends of theEustachian tube, or any combination thereof. In another embodiment, theshell provides sufficient air communication between the proximal end andthe distal end of the Eustachian tube, gas communication between theproximal end and the distal end of the Eustachian tube, fluidcommunication between the proximal end and the distal end of theEustachian tube, or any combination thereof.

In another embodiment, the device as described herein providing aircommunication between the ends of the Eustachian tube, gas communicationbetween the ends of the Eustachian tube, fluid communication between theends of the Eustachian tube, or any combination thereof is/aresufficient to effect pressure equilibration between the ends of theEustachian tube. In another embodiment, the device as described hereinproviding air communication between the ends of the Eustachian tube, gascommunication between the ends of the Eustachian tube, fluidcommunication between the ends of the Eustachian tube, or anycombination thereof is/are sufficient to equilibrate the pressurebetween the ends of the Eustachian tube. In another embodiment, thedevice as described herein providing air communication between the endsof the isthmus, gas communication between the ends of the isthmus tube,fluid communication between the ends of the isthmus, or any combinationthereof is/are sufficient to effect pressure equilibration between theends of the isthmus. In another embodiment, the device as describedherein providing air communication between the ends of the device, gascommunication between the ends of the device, fluid communicationbetween the ends of the device, or any combination thereof is/aresufficient to equilibrate the pressure between the ends of theEustachian tube.

In another embodiment, the device as described herein providing aircommunication between the ends of the isthmus, gas communication betweenthe ends of the isthmus tube, fluid communication between the ends ofthe isthmus, or any combination thereof is/are sufficient to effectpressure equilibration between the ends of the Eustachian tube.

In another embodiment, the construction of the device varies dependingon the functionality desired. In another embodiment, the device isconstructed according to the physiology of the subject into whoseEustachian tube is intended to receive. In another embodiment, aconstructing factor is the specie of a subject. In another embodiment, aconstructing factor is the age of a subject. In another embodiment, aconstructing factor is the medical condition to be treated in a subject.In another embodiment, the subject is a human.

In another embodiment, the subject is an infant. In another embodiment,the subject is a child. In another embodiment, the subject is an adult.In another embodiment, the subject is a teenager. In another embodiment,the subject is a senior. In another embodiment, the subject is a mammal.In another embodiment, the subject is a pet. In another embodiment, thesubject is a horse. In another embodiment, the subject is a farm animal.In another embodiment, the subject is a domesticated animal. In anotherembodiment, the subject is a nondomesticated animal. In anotherembodiment, the subject is any subject having an isthmus within aEustachian tube.

In another embodiment, the device treats or prevents otitis media. Inanother embodiment, the device treats or prevents otitis media witheffusion. In another embodiment, the device treats or preventsEustachian tube dysfunction. In another embodiment, the device treats orprevents chronic retraction of the tympanic membrane. In anotherembodiment, the device treats or prevents chronic otitis media. Inanother embodiment, the device treats or prevents patulous ET.

In another embodiment, the device prevents narrowing of the isthmus. Inanother embodiment, the device prevents narrowing of the Eustachiantube. In another embodiment, the device prevents diseases associatedwith narrowing of the Eustachian tube. In another embodiment, the deviceprevents diseases associated with narrowing of the isthmus. In anotherembodiment, the device prevents medical conditions associated withnarrowing of the isthmus. In another embodiment, the device is used fortreating medical conditions associated with narrowing of the isthmus. Inanother embodiment, the device aerates the middle ear. In anotherembodiment, the device is a portal to drain fluid and infection from themiddle ear. In another embodiment, the device treats retracted eardrums.In another embodiment, the device treats ear congestion. In anotherembodiment, the device prevents pressure related damage to the ear. Inanother embodiment, the device equilibrates pressure in the ear. Inanother embodiment, the device reduces high pressure in the ear. Inanother embodiment, the device increases low pressure in the ear. Inanother embodiment, the device equilibrates pressure in the earassociated with high altitude such as airplane travel. In anotherembodiment, the device equilibrates pressure in the ear associated withdiving. In another embodiment, the device equilibrates pressure in theear associated with over known altitude activities.

In another embodiment, the device enables the insertion of fiberopticinstruments through the isthmus. In another embodiment, the deviceenables diagnostic microendoscopy of Eustachian tube and the middle ear,and serve as a conduit for the diagnosis and assessment of middle andinner ear functions, integrity of the ossicles, chronic ear infectionand cholesteatoma. In another embodiment, the device serves as a stentand protective dressing for the isthmus In another embodiment, thedevice serves as a stent and protective dressing for the Eustachiantube.

In another embodiment, the device enables the insertion of fiberopticinstruments through the Eustachian tube. In another embodiment, thedevice enables diagnostic microendoscopy of Eustachian tube and themiddle ear, and serve as a conduit for the diagnosis and assessment ofmiddle and inner ear functions, integrity of the ossicles, chronic earinfection and cholesteatoma. In another embodiment, the device serves asa stent and protective dressing for the Eustachian tube.

In another embodiment, the device is constructed from biocompatibleimplantable material or materials. In another embodiment, the devicecomprises biomechanical properties that provide end forces necessary tokeep the Eustachian tube orifice. In another embodiment, the devicecomprises biomechanical properties that provide end forces necessary tokeep the isthmus orifice. In another embodiment, the device comprises ashell. In another embodiment, the shell is an insertable member.

In another embodiment, the device comprises a shell (FIGS. 2 and 3)having a dual cone (1, 2), head to head shape with two ends (3, 4), theproximal end (3) and the distal end (4) and an intermediate portion (5).In another embodiment, the device comprises a coaxial shell having adual cone, head to head shape with two ends, the proximal end resultingin an opening and the distal end resulting in an opening (FIGS. 2 and3). In another embodiment, a device comprising a coaxial shell having adual cone, head to head shape with two ends, the proximal end and thedistal end also comprises a valve (6). In another embodiment, a devicecomprising a coaxial shell having a dual cone, head to head shape withtwo ends, the proximal end and the distal end also comprises a pressurebiasing valve. In another embodiment, a device comprising a coaxialshell having a dual cone, head to head shape with two ends, the proximalend and the distal end also comprises a valve for equilibrating pressurebetween the proximal and distal ends of the shell. In anotherembodiment, a device comprising a coaxial shell having a dual cone, headto head shape with two ends, the proximal end and the distal end alsocomprises a pressure actuated valve (6). In another embodiment, a devicecomprising a coaxial shell having a dual cone, head to head shape withtwo ends and an immobilizing means (stopper (7)). In another embodiment,a device comprising a coaxial shell having a dual cone, head to headshape with two ends, the proximal end and the distal end also comprisesa pressure actuated valve (6) and an immobilizing means (stopper (7))(FIG. 3).

In another embodiment, the pressure actuated valve blocks air flowthrough the Eustachian tube. In another embodiment, the pressureactuated valve blocks fluid flow through the Eustachian tube. In anotherembodiment, the pressure actuated valve blocks gas flow through theEustachian tube. In another embodiment, the pressure actuated valve is arotating disc. In another embodiment, the pressure actuated valve has aball shape. In another embodiment, pressure actuated valves are known toone of ordinary skill in the art.

In another embodiment, the pressure actuated valve blocks air flowthrough the isthmus. In another embodiment, the pressure actuated valveblocks fluid flow through the isthmus. In another embodiment, thepressure actuated valve blocks gas flow through the isthmus. In anotherembodiment, the pressure actuated valve is a rotating disc. In anotherembodiment, the pressure actuated valve has a ball shape. In anotherembodiment, pressure actuated valves are known to one of ordinary skillin the art. In another embodiment, pressure actuated valves are flowershaped wherein the leaves of the flower are wide in the periphery andnarrow in the center. In another embodiment, pressure actuated valvespivot thus creating horizontal axis rotation in response to pressurechanges. In another embodiment, pressure actuated valves are known toone of average skill in the art. In another embodiment, pressureactuated valves comprise two cones which move forward as response topressure thus creating a seal.

In another embodiment, the valve is in a close position in steady state.In another embodiment, pressure exerted from the proximal end of thedevice actuates the valve, thus opening it. In another embodiment,pressure exerted from the distal end of the device actuates the valve,thus opening it.

In another embodiment, the pressure actuated valve opens upon exerting apressure of above 20 mmHg between the proximal and the distal ends(either way). In another embodiment, the pressure actuated valve opensupon exerting a pressure of above 30 mmHg between the proximal and thedistal ends (either way). In another embodiment, the pressure actuatedvalve opens upon exerting a pressure of above 40 mmHg between theproximal and the distal ends (either way). In another embodiment, thepressure actuated valve opens upon exerting a pressure of above 50 mmHgbetween the proximal and the distal ends (either way).

In another embodiment, the pressure actuated valve opens upon exerting apressure of above 50 mmH2O between the proximal and the distal ends(either way). In another embodiment, the pressure actuated valve opensupon exerting a pressure of above 70 mmH2O between the proximal and thedistal ends (either way). In another embodiment, the pressure actuatedvalve opens upon exerting a pressure of above 80 mmH2O between theproximal and the distal ends (either way). In another embodiment, thepressure actuated valve opens upon exerting a pressure of above 90 mmH2Obetween the proximal and the distal ends (either way). In anotherembodiment, the pressure actuated valve opens upon exerting a pressureof above 100 mmH2O between the proximal and the distal ends (eitherway). In another embodiment, the pressure actuated valve opens uponexerting a pressure of above 110 mmH2O between the proximal and thedistal ends (either way). In another embodiment, the pressure actuatedvalve opens upon exerting a pressure of above 120 mmH2O between theproximal and the distal ends (either way). In another embodiment, thepressure actuated valve opens upon exerting a pressure of above 130mmH2O between the proximal and the distal ends (either way). In anotherembodiment, the pressure actuated valve opens upon exerting a pressureof above 140 mmH2O between proximal and the distal ends (either way). Inanother embodiment, the pressure actuated valve opens upon exerting apressure of above 150 mmH2O between the proximal and the distal ends(either way). In another embodiment, the pressure actuated valve opensupon exerting a pressure of above 175 mmH2O between the proximal and thedistal ends (either way). In another embodiment, the pressure actuatedvalve opens upon exerting a pressure of above 200 mmH2O between theproximal and the distal ends (either way).

In another embodiment, the device comprises a shell having a dualfunnel, nozzle to nozzle shape with two ends. In another embodiment, thefunnel's arch dimensions vary in order to fit a particular anatomyand/or promote immobilization of the device. In another embodiment, thedevice comprises a shell having a shape generally corresponding to dualacute isosceles head to head shape. In another embodiment, the devicecomprises a shell having a shape generally corresponding to dualisosceles head to head shape. In another embodiment, the shape of thedevice corresponds to the cross sectional area of the Eustachian tube,torus tubarius, isthmus, or any combination thereof.

In another embodiment, the dimensions of the device: (1) promoteinsertion through the isthmus; and (2) promote immobilization of thedevice thus anchoring it to the isthmus. In another embodiment, theimmobilization means (7) promote immobilization of the device. Inanother embodiment, the immobilization means anchor the device to theisthmus. In another embodiment, the dimensions of the device: promoteinsertion through the Eustachian tube; and promote immobilization of thedevice thus anchoring it to the Eustachian tube. In another embodiment,the immobilization means (7) promote immobilization of the device. Inanother embodiment, the immobilization means anchor the device to theisthmus. In another embodiment, the immobilization means anchor thedevice to a specific location within the Eustachian tube. In anotherembodiment, the immobilization means anchor the device to a specificlocation within the isthmus. In another embodiment, the immobilizationmeans anchor the device to a specific location within the proximalportion of the ET. In another embodiment, the device is a tubecomprising different portions wherein each portion has a differentdiameter. In another embodiment, the device is a tube which widenstowards its ends. In another embodiment, the device is a tube whichwidens from the intermediate portion towards its ends. In anotherembodiment, an intermediate portion is uniform with regard to itsdiameter. In another embodiment, an intermediate portion is uniform. Inanother embodiment, the intermediate portion is the narrowest portion ofthe device. In another embodiment, the intermediate portion (5) isdesigned to fit within the isthmus. In another embodiment, the proximaland distal ends (3, 4) protrude out of the isthmus and to the Eustachiantube. In another embodiment, the proximal and distal ends protrude outof the isthmus and to the Eustachian tube thus anchoring the devicecomprising a shell to the isthmus. In another embodiment, the proximaland distal ends protrude out of the isthmus and to the Eustachian tubethus contributing to the immobilization of the device comprising ashell. In another embodiment, the proximal and distal ends are elasticand thus the insertion of the device into the isthmus is enabled. Inanother embodiment, the device is designed to occupy only the proximalportion of the ET and thus comprises a cone shape, a funnel shape or atriangular shape which fits between the proximal end of the isthmus or0.1-5 mm proximal to the proximal end of the isthmus and towards theproximal end of the ET.

In another embodiment the proximal portion of the ET is thecartilaginous portion of the ET. In another embodiment the distalportion of the ET is the osseous of the ET.

In another embodiment, the narrowest portion of the Eustachian tube isthe isthmus, which ranges in dimension from 2 to 3 mm vertically and 1to 1.5 mm horizontally. In another embodiment, the diameter of anycross-section within the intermediate portion does not exceed 5 mm. Inanother embodiment, the diameter of any cross-section within theintermediate portion does not exceed 4.5 mm. In another embodiment, thediameter of any cross-section within the intermediate portion does notexceed 4 mm. In another embodiment, the diameter of any cross-sectionwithin the intermediate portion does not exceed 3.5 mm. In anotherembodiment, the diameter of any cross-section within the intermediateportion does not exceed 3 mm. In another embodiment, the diameter of anycross-section within the intermediate portion does not exceed 2 mm. Inanother embodiment, the diameter of any cross-section within theintermediate portion does not exceed 1.5 mm. In another embodiment, thediameter of any cross-section within the intermediate portion does notexceed 1 mm. In another embodiment, the length of the intermediateportion is 1-6 mm. In another embodiment, the length of the intermediateportion is 1-5 mm. In another embodiment, the length of the intermediateportion is 2-5 mm. In another embodiment, the length of the intermediateportion is 2-4 mm. In another embodiment, the length of the intermediateportion is 2-3 mm.

In another embodiment, the diameter of the proximal end is larger than 3mm. In another embodiment, the diameter of the proximal end is largerthan 3.5 mm. In another embodiment, the diameter of the proximal end islarger than 4 mm. In another embodiment, the diameter of the proximalend is larger than 4.5 mm. In another embodiment, the diameter of theproximal end is larger than 5 mm. In another embodiment, the diameter ofthe proximal end is larger than 5.5 mm. In another embodiment, thediameter of the proximal end is larger than 6 mm. In another embodiment,the diameter of the proximal end is larger than 6.5 mm. In anotherembodiment, the diameter of the proximal end is larger than 7 mm. Inanother embodiment, the diameter of the proximal end is larger than 8mm.

In another embodiment, the device dilates the Eustachian tube. Inanother embodiment, the device dilates and stents the Eustachian tube.In another embodiment, the device stents the isthmus. In anotherembodiment, the device ventilates the middle ear.

In another embodiment, the device comprises a structural memory tomaintain its shape. In another embodiment, the device comprises a shellhaving opposing ends or ends (3, 4). In another embodiment, the deviceis formed at least in part from a biocompatible material.

In another embodiment, the opposing ends are connected by a peripheralsurface. In another embodiment, at least one exterior surface have ashape that substantially corresponds to a cross sectional area of theEustachian tube. In another embodiment, at least one exterior surfacehave a shape that substantially corresponds to a cross sectional area ofthe isthmus. In another may have any desired contour, e.g., jagged,undulated, etc.

In another embodiment, the length of the device is greater than thewidth of the device. In another embodiment, the length of the deviceextends the width by at least 100%. In another embodiment, the length ofthe device extends the width by at least 200%. In another embodiment,the length of the device extends the width by at least 300%. In anotherembodiment, the length of the device extends the width by at least 400%.In another embodiment, the device is constructed for insertion into theisthmus in an ear, left or right, the device may have a member geometrythat exhibits mirror symmetry. In another embodiment, the device isconstructed for insertion into the Eustachian tube in an ear, left orright, the device may have a member geometry that exhibits mirrorsymmetry.

In another embodiment, the shell and the immobilization means (7) havean integrated construction. In another embodiment, the device havemechanical properties that provide forces necessary to render the deviceimmobile, e.g., the member may be at least partially elasticallydeformable before immobilization. In another embodiment, the deviceitself is formed from a material compounded with one or more adhesives.In another embodiment, an adhesive is applied as an interfacialcomposition between the shell and the isthmus. In another embodiment, anadhesive is applied as an interfacial composition between the shell andthe Eustachian tube.

In another embodiment, the device has dimensions that are designed toprovide a slit between the shell's exterior surface and the isthmus. Inanother embodiment, the device has dimensions that are designed toprovide a slit between the shell's exterior surface and the Eustachiantube. In another embodiment, the surface of the device is not in fullcontact with the isthmus. In another embodiment, the surface of thedevice is not in full contact with the Eustachian tube. In anotherembodiment, the device is in contact with the Eustachian tube atpredefined locations. In another embodiment, these predefined locationsserve as immobilizing means. In another embodiment, these predefinedlocations serve as posterior or anterior pillars.

In another embodiment, the device is effective in equilibrating anyfluid-generated pressure between the proximal and distal ends of thedevice. In another embodiment, the device is effective in equilibratingany gas-generated pressure between the proximal and distal ends of thedevice.

In another embodiment, the invention pertains to a method for insertinga device into a Eustachian tube in a subject providing pressurecontrolled ventilation, and enhanced drainage, or a combination thereofto a middle ear of a subject, comprising a shell, wherein the shellcomprises a proximal end, a distal end, wherein the device occupies atleast a portion of the proximal end of the Eustachian tube of a subject.In another embodiment, the device of occupis only the Eustachian tube.In another embodiment, the proximal end cross-section area is largerthan the distal end cross-section area. In another embodiment, thedevice further comprises an intermediate portion. In another embodiment,the proximal end and the distal end have a larger cross-section areathan the intermediate portion cross-section area, wherein theintermediate portion fits within the Eustachian tube in a subject.

In another embodiment, the invention pertains to a method for insertiona device into a Eustachian tube in a subject providing pressurecontrolled ventilation, and enhanced drainage, or a combination thereofto a middle ear of a subject, comprising a shell, wherein the shellcomprises a proximal end, a distal end, and an intermediate portion,wherein the proximal end and the distal end have a larger cross-sectionarea than the intermediate portion cross-section area, wherein theintermediate portion fits within the Eustachian tube in a subject. Inanother embodiment, the device is inserted through the nasopharynx intothe isthmus.

In another embodiment, the invention pertains to a method for insertinga device of the invention as described herein into a Eustachian tube ina subject. In another embodiment, the invention pertains to a method forinserting a device of the invention as described herein through theisthmus providing pressure control ventilation, and enhancedventilation, drainage, or a combination thereof to a middle ear of asubject.

In another embodiment, the invention pertains to a method for stentingthe Eustachian tube with a device as described herein, providingpressure controlled ventilation or enhanced drainage, or a combinationthereof to a middle ear of a subject.

In another embodiment, the invention pertains to a method for insertinga device through the isthmus and into a Eustachian tube of a subject. Inanother embodiment, the device is used to dilate the Eustachian tube atthe isthmus. In another embodiment, the device is used to providemechanical support to the Eustachian tube. In another embodiment, thedevice is used to provide mechanical support to isthmus. In anotherembodiment, the device is used to stent the Eustachian tube at theisthmus. In another embodiment, the device is used to stent the isthmus.

In another embodiment, the invention pertains to a method for insertingthe device as described herein into an Eustachian tube and through theisthmus of a subject, comprising: (a) loading the device onto aninsertion apparatus, wherein the device comprises a coaxial shell,wherein the shell comprises a proximal end, a distal end, and anintermediate portion, wherein the proximal end and the distal end have alarger cross-section area than the intermediate portion cross-sectionarea, wherein the intermediate portion fits within an isthmus in theEustachian tube in a subject; (b) inserting the device using theinsertion apparatus through a nostril or mouth of a subject into theisthmus; and (c) releasing the device from the apparatus in an isthmus.

In another embodiment, the invention provides a method for inserting adevice into a Eustachian tube of an animal. The method involvesinserting the device as described above through a nostril or mouth ofthe animal into the Eustachian tube. Optionally, the device is insertedsolely through the nasopharyngeal end of the Eustachian tube through thenose or the oropharynx in a manner that does not involve making anyincision to an eardrum or ear canal skin. The device may then bereleased manner effective to allow the device to immobilize itselfwithin the Eustachian tube at its end in the nasopharynx. The method maybe performed with general anesthesia, local anesthesia, or sedation asappropriate.

In another embodiment, the method of placement of the device is via thenasal passageways and nasopharyngeal end of the Eustachian tube and doesnot require incision of the eardrum, ear canal or entry into the middleear. In another embodiment, the method of placement of the device is viathe oral passageways and nasopharyngeal end of the Eustachian tube anddoes not require incision of the eardrum, ear canal or entry into themiddle ear.

In another embodiment, the method comprises loading the device onto aninsertion apparatus and using the insertion apparatus to insert thedevice through a nostril or mouth of a subject into the isthmus. Inanother embodiment, the method comprises loading the device onto aninsertion apparatus and using the insertion apparatus to insert thedevice through a nostril or mouth of a subject through the Eustachianand into the isthmus. In another embodiment, once the device is inplace, the device is released from the apparatus in a manner effectiveto allow the device to immobilize itself within the isthmus.

In another embodiment, the method comprises endoscopy, in conjunctionwith surgery or in the absence of any incision. In another embodiment,the method is effective to dilate the Eustachian tube. In anotherembodiment, the method is effective to permanently

In another embodiment, the method is effective to prevent collapse ofthe Eustachian tube.

In another embodiment, the device is effective in treating certain typesof hearing loss. In another embodiment, the device is effective intreating ear discomfort. In another embodiment, the device is effectivein treating dysfunction of the Eustachian tube. In another embodiment,the device is effective in treating inflammation affecting theEustachian tube. In another embodiment, the device enables diagnosticmicroendoscopy of Eustachian tube and the middle ear, and serves as aconduit for the diagnosis and assessment of middle and inner earfunctions, integrity of the ossicles, chronic ear infection andcholesteatoma. In another embodiment, the device serves as a stent andprotective dressing for any hard and soft palate, nasopharyngeal, orEustachian tube surgery.

In another embodiment, the device is effective in treating retractedeardrums and ear congestion. In another embodiment, by dilating andstenting the Eustachian tube, barometric Eustachian tube dysfunction istreated, and pressure related damage to the ear are prevented. Inanother embodiment, allergic and/or infectious Eustachian tubedysfunction is treated by the device. In another embodiment, chronic andacute Eustachian tube dysfunction is treated by the device.

In another embodiment, when placed in the isthmus at the Eustachian tubethrough a minimally invasive procedure that results in device placementthrough the nasal passages through the nasopharynx or the oropharynx,the device confers a number of advantages. In another embodiment, thebenefits of a nasopharyngeal-based therapy are achieved without thedisadvantages of the undesirable outcomes associated with treatmentmethods that involve an incision in the ear canal or eardrum, or entryinto the middle ear space. In another embodiment, such placement of thedevice in the ET provides immediate relief from fluid in the ear andpressure related maladies.

In another embodiment, the insertion apparatus is used to place thedevice into the isthmus within the Eustachian tube. In anotherembodiment, the insertion apparatus may have a number of designs andconstruction. In another embodiment, the insertion apparatus isendoscopic and hand held in construction. In another embodiment, theapparatus provides a user sufficient degree of control over theinsertion of the device in a minimally invasive manner so as to minimizetrauma or discomfort to a patient. In another embodiment, the apparatusprovides for precisely and accurately controlled translational (e.g.,X-Y-Z) and/or, rotational (.theta.-.phi.) movement capabilities. Inanother embodiment, the apparatus allows for one, two, three, four,five, six, or more degrees of freedom.

In another embodiment, the apparatus have a device-interfacing terminusand a manipulation terminus. In another embodiment, thedevice-interfacing terminus have a construction specific to the deviceor is used to interface with devices other than those described herein.In another embodiment, the interfacing terminus has a solid or hollowgeometry specific to the device. In another embodiment, the interfacingterminus provides for functionality associated with the practice of themethod.

In another embodiment, the manipulation terminus houses a means forreleasing any device engaged therewith. In another embodiment, thereleasing means has a spring-loaded mechanism, or manual releasemechanism that allows the device to be releasably engageable withdevice-interfacing terminus of the apparatus. In another embodiment, thedevice is controllably slid from the insertion apparatus into theEustachian tube.

In another embodiment, the device is constructed with a means forinterfacing with the insertion apparatus. In another embodiment, suchmeans serve no other purpose than to interface with the insertionapparatus. For example, the interfacing means may include at least oneprotrusion extending from an exterior surface by which the insertiondevice may grab. As another example, one or more tabs or fenestrationsmay be located on other or both front and back surfaces of the devicearound the fluid-communication providing means.

In another embodiment, the interfacing means serves a plurality ofpurposes. In another embodiment, the shell is effective to serve asmeans for engaging with the insertion apparatus.

In another embodiment, the interfacing means is used to make adjustmentsto the device to be inserted and/or extracted. In another embodiment,the interfacing means is used to adjust the shell size before insertion.In another embodiment, the interfacing means is used to stretch theshell before insertion. In another embodiment, the interfacing means isused to squeeze the shell before insertion.

In another embodiment, the device is packaged with the insertionapparatus to form a kit. In another embodiment, the kit comprisesinstruction for using the apparatus with the device. In anotherembodiment, the kit keeps the device sterile. In another embodiment, thekit keeps the insertion apparatus sterile. In another embodiment, thekit keeps the device and the insertion apparatus sterile. In anotherembodiment, the kit keeps the device and the insertion apparatus inminimized dimensions.

Experimental Details Section

Insertion Procedure

Device 8 or 9 (FIGS. 2 and 3) is inserted through the nasopharyngealorifice as described below, such that surgery and lifting of thetympanic membrane is not required.

The patient is placed in a supine position on the operating table undereither general or local anesthesia. Ephedrine is administeredintranasally.

The nose is inspected using a 2.4-4 mm or narrower flexible or rigidendoscope fitted with a video camera processor and a light source,attached to a guide with a Stent placed on it. After reaching thenasopharynx, the Eustachian tube orifice is identified, and then usingangulations of the endoscope and the guide, it is inserted and placed.Once the Stent is in place, a catheter is used to conduct suction of themiddle ear. Finally, the endoscope is removed from the nasal cavity. Insome cases a inflation of the tube by air will done before inserting thestent.

Turning now to FIGS. 1-3, it is to be understood that such figures showspecific examples of the devices and methods of the present invention.Any elements, attributes, components, accessories or features of oneembodiment or example shown in these figures may be eliminated from thatembodiment or example, or may be included in any other embodiment orexample, unless to do so would render the resultant embodiment orexample unusable for its intended purpose.

FIG. 1 generally shows a diagram of the inner ear of a human patientwherein device 8 is being implanted in the Eustachian tube. As shown,device 8 comprises a valve 6 and a narrow intermediate portion 5 thatfits and or fastens device 8 to the isthmus within the Eustachian tube.Valve 6 is an open position due to elevated pressure, allowing air andfluid communication between the proximal (3) and distal (4) ends of thedevice 8.

Prior to or after insertion of the device, the implantable device isloaded onto the insertion apparatus into the lumen of Eustachian tube ina parallel position to the Eustachian tube and the isthmus, thusproviding mechanical support to the isthmus. The structure anddimensions of the shell of device 8 allow contact between the shell and:(a) the isthmus (intermediate portion 5) and (b) the Eustachian tube(proximal and distal portions), in some discrete portions, but stillallow sub-millimeter spaces in other discrete locations of the shell,in-between the shell and the underlying tissue. In a case that suchcompression for deployment is not possible, the size of the narrowestpart and the distal part will be the same and a wider stopper will beplaced inside the lumen of the stent to prevent re-compression andmigration.

FIG. 2 is a side view of the device with an optional leaf valvepositioned in the distal side in accordance with an embodiment of theinvention. The exact measurements of the stent are calculated accordingto age and size of the Eustachian tube. Thus, the Stent may assume or beprovided in several sizes. In this example, the Stent's proximal innerdiameter is 7.6 mm and outer diameter 8.0 mm. The Stent's distal innerdiameter is 4.6 mm and outer diameter 5 mm. The inner diameter at thenarrowest part is about 1-1.5 mm and outer diameter 3.5 mm. The proximallength is 16 mm (or less) and the distal length 8.5 mm (or less). Thenarrowest part's length is 1 mm. Other dimensions are possible. Thevalve is placed in the distal side and it might be one directional ortwo directional as needed. There is also possibility of positioning thevalve in the proximal part or not to put a valve at all. The shape,texture and finish of the device wall vary, such as for example spiral,network or a smooth texture depending on the material chosen, drainageneeds or other consideration.

FIG. 3—is similar to FIG. 2, but the valve is in a ball shape, and itincludes a stopper that assists to prevent the migration of the devicewithin the Eustachian tube and out of the isthmus. The stopper may alsoprevent a compression of the deployed stent that could allow the stentto migrate back through the isthmus. Other known means of preventingcollapse of the device can be deployed by one of average skill in theart.

What is claimed:
 1. A device adapted for insertion into a Eustachiantube, said device comprising a shell, said shell comprising: a proximalend and a distal end; and a tube extending from said proximal end tosaid distal end, said tube being closed in a resting position, andopened by air pressure differential between said ends when air pressureexerted at the proximal end is higher than air pressure exerted at thedistal end and when air pressure exerted at the distal end is higherthan air pressure exerted at the proximal end; and wherein said deviceis adapted for insertion into said Eustachian tube through anasopharynx.
 2. The device of claim 1, wherein an intermediate portionof the device fits within said Eustachian tube.
 3. The device of claim1, wherein at least a portion of the device is compressible.
 4. Thedevice of claim 1, further comprising an immobilizing means forimmobilizing said device in a position in said Eustachian tube.
 5. Thedevice of claim 4, wherein said immobilizing means is located in saidEustachian tube when the device is positioned in said Eustachian tube.6. The device of claim 1, further comprising a pharmacologically activeagent.
 7. The device as in claim 1, further comprising a pressureactuated artificial valve situated between said proximal end and saiddistal end, said valve serving to close said tube in said restingposition and to open said tube upon occurrence of said air pressuredifferential.
 8. The device of claim 7, wherein in closed position, saidpressure actuated artificial valve blocks air flow and liquid flowthrough said Eustachian tube.
 9. The device of claim 7, wherein saidpressure actuated artificial valve is configured to open only uponoccurrence of an air pressure differential of above 200 mmH₂O betweensaid proximal and said distal ends.
 10. The device of claim 7, whereinsaid pressure actuated artificial valve, in an open position, providesliquid flow through said Eustachian tube.
 11. The device of claim 7,wherein said pressure actuated artificial valve, in an open position,provides gas flow through said Eustachian tube.
 12. The device of claim1, wherein said tube when opened provides unidirectional flow of liquidbetween said ends from a middle ear to said nasopharynx.
 13. The deviceof claim 1, wherein said tube when opened provides bi-directional flowof air between said ends.
 14. The device of claim 1, wherein said deviceoccupies only a cartilaginous portion of the Eustachian tube.
 15. Thedevice of claim 1, wherein said tube is opened autonomously based onsaid air pressure differential and closed autonomously when said airpressure differential is equalized.
 16. A method for insertion of adevice into a Eustachian tube, comprising: loading said device onto aninsertion apparatus, said device comprising: a proximal end, a distalend, an intermediate portion and a tube extending from said proximal endto said distal end through said intermediate portion, said tube beingclosed in a resting position, and opened by air pressure differentialbetween said ends when air pressure exerted at the proximal end ishigher than air pressure exerted at the distal end and when air pressureexerted at the distal end is higher than air pressure exerted at theproximal end; wherein at least a portion of said device, upon saidinsertion is adapted to fit within said Eustachian tube; inserting saiddevice using said insertion apparatus into said Eustachian tube througha nasopharynx; and releasing said device from said apparatus upon deviceinsertion into said Eustachian tube.
 17. The method of claim 16, furthercomprising fitting said intermediate portion of the device within anisthmus.
 18. The method of claim 16, further comprising compressing atleast a portion of said device to fit within an isthmus.
 19. The methodof claim 16, further comprising immobilizing said device upon saidreleasing.
 20. The method of claim 16, wherein said tube is opened byopening a pressure actuated artificial valve situated between saidproximal end and said distal end to equalize the air pressuredifferential between said distal end and said proximal end.
 21. Themethod of claim 16, wherein said inserting is through a nostril.
 22. Themethod of claim 16, wherein said inserting comprises locating saiddevice wholly within a cartilaginous portion of the Eustachian tube. 23.The method of claim 16, further comprising releasing a pharmacologicallyactive agent from said device.
 24. The method of claim 16, furthercomprising adapting said tube to open only upon occurrence of an airpressure differential of above 200 mmH₂O between said proximal and saiddistal ends.
 25. The method of claim 16, wherein the device is packed ina compressed form and extends along the Eustachian tube.